Endoscopic tissue apposition device and method of use

ABSTRACT

An endoscopic tissue apposition device that includes a vacuum chamber configured to securely hold a portion of tissue therein, the vacuum chamber being defined by a proximal wall and a distal wall opposite to the proximal wall. Working and vacuum channels are provided in communication with the vacuum chamber. A portion of tissue may be held in the vacuum chamber when vacuum is applied in the vacuum chamber through the vacuum channel. A carrier needle is disposed on a proximal side of the vacuum chamber and is longitudinally advanceable into and across the vacuum chamber, while a punch needle is disposed on a distal side of the vacuum chamber and is configured to receive the carrier needle therein. A hold and release mechanism holds and releases the punch needle to facilitate joining portions of tissue together.

RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.11/074,668, filed on Mar. 9, 2005, which claims the benefit of U.S.Provisional Application No. 60/604,687, filed on Aug. 27, 2004, each ofwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present application relates to an improved endoscopic appositiondevice and method of use for treating patients suffering from obesityand other such gastric ailments. Specifically, the invention provides anendoscopic apposition device configured to collect a plurality ofstomach tissue portions and sew or suture the tissue portions togetherusing the apposition device.

BACKGROUND OF INVENTION

Obesity arguably is one of the most serious health problems in theUnited States as well as the world, affecting millions of people of allages. Apart from the physical and psychological effects, especially onthe younger population, obesity predisposes individuals to seriousdiseases, such as coronary artery disease, hyperlipidemia, hypertensionand diabetes mellitus. The costs to the health system in the UnitedStates alone are estimated to be over thirty-nine billion dollars peryear.

Weight reduction can be achieved either by increasing caloricexpenditures through exercise and/or by reducing caloric intake.Reducing caloric intake can be achieved in a number of ways, such assurgical procedures to reduce the stomach capacity or to reduce the foodtransit time in the gastrointestinal tract, by using appetitesuppressants like amphetamines or noradrenergic compounds, or via othermethods, such as introducing balloons into the stomach. The appetitesuppressants act on the central nervous system and are associated withconsiderable morbidity and side effects. Balloon inserts have severaldisadvantages, which include failure due to bursting or dislodging,intestinal obstruction (blockage of the intestinal lumen), and arequirement of use of complicated devices and/or procedures to securethe balloon within the stomach.

Historically, numerous patents have been issued for devices and methodsfor treating obesity and other such gastric related ailments. Forexample, U.S. Pat. No. 4,899,747, issued Feb. 13, 1990, to Garren etal., discloses a method and apparatus for treating obesity. Inparticular, the apparatus is a flexible, free floating and unattachedinflatable balloon that is inserted into the stomach. Upon insertioninto the stomach, the balloon is then inflated to reduce the stomachvolume of the patient. U.S. Pat. No. 4,694,827, issued Sep. 22, 1987 toWeiner et al., discloses another balloon based approach for treatingobesity. In particular, the balloon, when inflated, has a plurality ofsmooth surfaced convex protrusions disposed in locations that permit theballoon to engage the stomach wall at specific locations.

U.S. Pat. No. 5,686,141, issued Feb. 9, 1999 to Y. A. Ellias, disclosesan endoscopic stomach insert having a plurality of flexible bladescoupled at one end thereof to a base portion and circumferentiallyarranged around the central axis of the base. A retainer is provided toreleasably couple the distal portions of the blades within closeproximity of each other.

U.S. Pat. No. 5,423,872, issued Jun. 13, 1995 to V. Cigaina, discloses aprocess for treating obesity involving the sequential application ofelectrical pulses to the stomach for preset periods of time. Anotherpatent to V. Cigaina, i.e., U.S. Pat. No. 6,615,084 issued Sep. 2, 2003,discloses another technique for electro-stimulation of the lessercurvature of the stomach, most preferably on the lower or distal end ofthe lesser curvature, wherein the lesser curvature is stimulated at arate of 2-14 pulses per minute.

U.S. Pat. No. 6,540,789, issued Apr. 9, 2003, to Silverman et al.,discloses a method for treating morbid obesity involving at least oneimplant positioned in the wall near the pyloric sphincter to inhibitemptying of the stomach. In yet another example of an implantabledevice, U.S. Pat. No. 6,611,715, issued Aug. 26, 2003, to B. R. Boveja,discloses an apparatus and method for neuromodulation to treat obesityand compulsive eating disorders using an implantable lead-receiver andan external stimulator. The external stimulator emits electrical pulsesthat stimulate the vagus nerve. The external stimulator contains a powersource, control circuitry, a primary coil, and predetermined programs tocontrol the different levels of therapy.

U.S. Pat. No. 6,627,206, issued Sep. 30, 2003, to G. A. Lloyd, disclosesa technique for treating obesity using a mechanism for the time releaseof medications. In particular, a plurality of space-filling portions aresized to be received within the patient's body, wherein the portionscome together in the patient's body to form a structure that providestherapeutic benefits to the patient.

U.S. Pat. No. 6,535,764, issued Mar. 18, 2003 to Imran et al., disclosesa device and method for diagnosing and treating gastric disorders. Thedevice is positioned within the stomach of the patient and securedthereto by an attachment mechanism. The device can either be a sensorfor sensing various parameters of the stomach or stomach environment ora therapeutic delivery device. In one embodiment, the device providesgastric electrical stimulation, wherein stimulating electrodes aresecured to the stomach wall by the attachment mechanism. An electronicsunit contains the electronic circuitry of the device, and the device isprogrammable to respond to the sensed information or signals. Anendoscopic delivery system delivers the device through the esophagusinto the stomach, wherein the device is attached to the stomach wall.Endoscopic instruments are then attached to the device and attachmentmechanism and are used to assist in determining the optimal attachmentlocation on the stomach wall.

U.S. Pat. No. 6,755,869, issued Jun. 29, 2004, to Geitz, discloses aprosthesis formed from a porous weave of bio-absorbable filaments havingan open mesh configuration that is formed into an oblate shape havingdimensions that are greater than the esophageal opening and gastricoutlet of the stomach. The prosthesis is deployed in the stomach tolimit the amount of food that may be held within the stomach as well asto apply pressure on the fundus, so as to create a sensation of beingfull.

Another example of a device for treating obesity and other such gastricailments includes an elastic band installed around the external wall ofthe patient's stomach to reduce the internal volume thereof. As aresult, the patient requires less food to achieve a sensation of beingfull and typically loses substantial amounts of weight in a relativelyshort period of time.

Yet another example of a device that is used to treat obesity and othersuch gastric ailments is the use of an endoscopic apposition device tosew or suture portions of a patient's stomach tissue together. U.S. Pat.No. 5,080,663, issued Jan. 14, 1992, to Mills et al., U.S. Pat. No.5,792,153, issued Aug. 11, 1998, to Swain et al., as well as U.S. PatentApplication Publication No. 2003/0208209, published Nov. 6, 2003, toGamble et al., and WO Patent Application Publication No. 2004/103189,published Dec. 2, 2004, to Gamble et al., each disclose various types ofendoscopic apposition devices.

Endoscopic apposition devices are used without having to make anexternal incision in the patient, and are controlled externally of thepatient by endoscopic means. Apposition devices typically include asewing or stapling device for use with a flexible endoscope, althoughendoscopic apposition devices can also be used with a rigid endoscope.

For example, to stitch or sew together certain portions of stomachtissue, the apposition device, such as a sewing capsule, is attached tothe end of a viewing endoscope and inserted through the esophagus of apatient to form a plurality of stitches in stomach tissue slightly belowthe lower end of the esophagus. A first stitch is made through stomachtissue to one side of the esophagus, and a second stitch is made, withthe same suture thread, in stomach tissue adjacent to the first stitch.The two stitches are then drawn together to pull together thediametrically opposed, stitched stomach portions.

After the sutures are applied, the endoscope is removed from the patientand a knot is tied with the free ends of the suture thread that extendoutside of the patient. The knot is pushed down to the site of thesutures by a thread guide device that has been positioned at the distalend of the endoscope. The suturing and knotting procedure is repeatedseveral times. After a sufficient number of knots and sutures have beenplaced, a thread cutter, also operable through the endoscope, is used tocut the suture thread at points that are close to the tissue.

In general, the '663 patent to Mills et al. and the '153 patent to Swainet al. disclose a sewing device positioned on the distal end of anendoscope and used to pass a thread through a portion of stomach tissue.The sewing device includes a hollow needle movable between a firstposition in which the needle is out of the stomach tissue and a secondposition in which the needle passes through the portion of stomachtissue, and a thread carrier that is attached to the thread and isreceived within the needle. The sewing device also includes a body,which defines a cavity within which the portion of stomach tissue isheld by a suction force, and within which the needle is mounted formovement between first and second positions.

A more particular or specific description of how the conventionalendoscopic appositions devices operate will now be provided using thedevice disclosed by the '153 patent to Swain et al. as an example. Thedescription of how the device disclosed by the '153 patent to Swain etal. operates will also be instrumental in understanding the differenceswith the operation and the present invention, which will be described indetail below.

FIGS. 1-3 illustrate the conventional endoscopic apposition devicedisclosed in the '153 patent to Swain et al.

FIG. 1 shows the distal end of a flexible endoscope 1, on which a sewingdevice 2 is attached. The endoscope 1 is provided with a viewing channel(not shown), which terminates at a lens on the distal face of theendoscope 1. The endoscope 1 is further provided with a working channel3 and a suction channel 4, the proximal end of the suction channel 4being connected to a source of vacuum (not shown).

The sewing device 2 includes a tube 5, which communicates with thesuction channel 4, and has a plurality of perforations 6 therein. Theperforations 6 communicate with an upwardly open vacuum chamber 7 formedin the sewing device 2.

A hollow needle 8 is mounted in the working channel 3 and has a beveledtip extending into the sewing device 2. The needle 8 has a channel 9extending therethrough, with a flexible, wire-wound cable 10 attached tothe rear of the needle 8. A center wire 11 extends within the cable 10,along the entire length thereof, and is longitudinally movable withrespect thereto. The wire 11 is configured to be longitudinally movablewithin the channel 9 and, in the position shown in FIG. 1, the forwardend portion of the wire 11 extends into the rear end portion of thechannel 9.

A thread carrier or tag 12 (FIG. 1A) is slidably and releasably mountedin the channel 9. The tag 12 is hollow and has an aperture 13 extendingthrough the sidewall thereof. One end of a thread 14 is secured to thetag 12 after passing through the aperture 13 and being tied in a knot 15of sufficient size to prevent the thread 14 from slipping out of the tag14.

A hollow head portion 16, defining a chamber 20 therein, is provided atthe distal end of the sewing device 2. A wall 17 is provided between thechamber 20 and the cavity 7, wherein an aperture 18 is formed in thewall 17. The aperture 18 has a diameter that is greater than an externaldiameter of the needle 8, and is aligned therewith. The clearancebetween the needle 8 and the aperture 18 must be sufficiently small toprevent stomach tissue from being forced through the aperture 18 andcausing the needle 8 to jam. Also, FIG. 1 illustrates a portion of thepatient's tissue 19, in which a stitch is to be formed.

In operation, suction is applied to the suction channel 4 and then tothe vacuum chamber 7 through the perforations 6 in the tube 5. As shownin FIG. 2, a U-shaped portion 19 a of stomach tissue 19 is sucked intothe vacuum chamber 7. The needle 8 is then pushed through the U-shapedtissue portion 19 a by distally extending the cable 10 and needle 8.After the needle 8 has been fully advanced through both folds of theU-shaped tissue portion 19 a, the beveled tip of the needle 8 extendsdistally beyond the wall 17 and within the chamber 20 in the hollow headportion 16. Distal movement of the wire 11, which is slidably receivedwithin the cable 10, pushes the tag 12 out of the channel 9 and into thechamber 20, where the tag 12 rotates out of alignment with the aperture18 and is captured in the chamber 20.

The wire 11 is then proximally withdrawn, followed by the proximalwithdrawal of the cable 10, to withdraw the needle 8 from the U-shapedtissue portion 19 a. The suction is then discontinued, allowing theU-shaped tissue portion 19 a to be released from the vacuum cavity 7.

As shown in FIG. 3, the released tissue is left with a suture thread 14passing through the two layers of tissue that form the U-shaped fold 19a. One end of the suture thread 14 is joined to the tag 12 that remainscaptured in the chamber 20 and the other end of the suture thread 14extends through the patient's esophagus and out of the mouth. Finally,the endoscope 1 and sewing device 2 are withdrawn from the patient. Inso doing, the thread 14 is pulled partially through the tissue portion19 a, as the captured tag 12 is withdrawn proximally and brought outsidethe patient. With both ends of the thread 14 outside of the patient, thethread 14 is knotted and the knot endoscopically pushed down to thesuture site and severed by an endoscopic knot pusher.

The '663 patent to Mills et al, as well as the '209 and '189 publishedpatent applications of Gambale et al., like the device disclosed by the'153 patent to Swain et al., each disclose endoscopic apposition deviceswherein the suture thread is retained proximal of the vacuum chamberprior to being threaded through the fold of stomach tissue. Each ofthese approaches presents certain problems. For example, with each, oncethe suture thread is passed through the fold of stomach tissue, thesuture thread is not retained in a taut manner and may interfere withsubsequent sewing or suturing procedures. Additionally, the vacuumchannels for each of the conventional apposition devices are provided inthe bottom or floor of their respective vacuum chambers. As such, thestomach tissue sucked into vacuum chamber can have a dimpled form.Therefore, the stomach tissue may not be securely retained in the vacuumchamber.

Furthermore, a problem exists in that several conventional devicesrequire the device to be withdrawn from the patient after each stitch orsuture made with a single-stitch device. The use of such devices is timeconsuming, cumbersome, and of some risk to the patient, due, forexample, to the multiple intubations and danger of perforations to theesophagus. Also, the patient is required to be kept under sedation for arelatively long period of time.

SUMMARY OF INVENTION

The present invention provides an endoscopic stomach tissue appositiondevice capable of securing a plurality of tissue sites together with asingle intubation of an endoscope carrying the apposition device at thedistal end of the endoscope into the stomach of the patient. To positionthe suture in the appropriate locations, the apposition device may bereleasably secured to the distal end of any suitable endoscope. Theapposition device includes a tissue vacuum chamber that captures asection of stomach tissue therein, nesting carrier and punch needlesthat can extend across the vacuum chamber, and a tag that is joined to asuture to prevent the suture from falling out of the apposition device.

According to one aspect of the present invention, the apposition deviceis secured to the distal end of a flexible endoscope, which may be ofthe flexible or rigid type of endoscope. The endoscope is provided witha working channel and a vacuum channel that is connected to a vacuumsource. Ideally, the vacuum channel comprises an internal channel withinthe apposition device and has a distal end that terminates at a vacuumchamber.

In one embodiment, a first or carrier needle having a hollow, beveledtip extending toward the vacuum chamber is disposed in the workingchannel. The beveled tip of the carrier needle is configured to receivea relatively shorter second or punch needle disposed within a holdingchamber located on the distal end of the endoscope, on the opposite ordistal side of the vacuum chamber. The punch needle also has a beveledtip that corresponds to the beveled tip of the carrier needle and isconfigured to receive the beveled tip of the carrier needle therein.

A holding channel is provided, for example, coaxial to the workingchamber. Accordingly, when actuated, the carrier needle travels acrossthe vacuum chamber and enters the holding channel. A release channel islocated directly above the holding channel in a vertical directionrelative to a bottom surface of the vacuum chamber. In one embodiment, aholding mechanism is located in the release channel and includes apivotable key, which has a cam profile, a slotted member, which has avertically extending slot incorporated therein to receive a pivot end ofthe key, and a biasing member.

The biasing member of this embodiment includes a cylinder slidablysupported by first and second support struts, which include aperturesformed therein that are configured to slidably receive the cylinder. Thecylinder includes a stop protruding therefrom, at a location on thecylinder that is constantly intermediate the support struts. An elasticcoil is wound around the cylinder in a spiral manner, such that a firstend of the coil is constantly engaging the stop and a second end engagesthe support strut located at the distal end of the endoscope.

According to an aspect of the invention, an endoscopic tissue appositiondevice is provided that reduces the number of intubations required toattach or repair internal tissue by a tissue securement mechanism thatuses a suture.

According to yet another aspect of the invention, an endoscopicapposition device is provided that is simple and economical to fabricateand use.

According to another aspect of the invention, a tissue apposition deviceis provided having longitudinal flexibility that is easily navigablethrough a natural body lumen while mounted at the distal end of anendoscope.

And yet another aspect of the invention provides a method of joiningstomach tissue that comprises capturing at least two areas of tissuesimultaneously to delivery tissue securement device through the areas oftissue to join them together.

Additional advantages and novel features of the invention will be setforth in part in the description that follows, and in part will becomemore apparent to those skilled in the art upon examination of thefollowing or upon learning by practice of the invention.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other aspects of the present invention will beappreciated more fully from the following description, with reference tothe accompanying drawings wherein:

FIGS. 1-3 show successive steps in the operation of a conventionalendoscopic apposition device;

FIG. 4 is a schematic diagram of an apposition device having a carrierneedle in a retracted position according to an embodiment of the presentinvention;

FIG. 4A is a perspective view of an isolated punch needle;

FIG. 5 is a schematic diagram showing the carrier needle in a slightlyextended position in accordance with an embodiment of the presentinvention;

FIG. 6 is a schematic diagram showing the carrier needle nested withinthe punch needle in accordance with an embodiment of the presentinvention;

FIG. 7 is a schematic diagram showing the nested carrier and punchneedles being retracted in accordance with an embodiment of the presentinvention;

FIG. 8 is a schematic diagram showing a U-shaped section of stomachtissue being sucked into the vacuum chamber and vacuum channel inaccordance with an embodiment of the present invention;

FIG. 9 is a schematic diagram showing the carrier and punch needlespiercing the U-shaped section of stomach tissue in accordance with anembodiment of the present invention;

FIG. 10 is a schematic diagram showing the sutured section of stomachtissue being retained by a suture and the carrier and punch needles intheir respective original stations in accordance with an embodiment ofthe present invention; and

FIGS. 11-16 illustrate the sequential steps of an exemplary process forsuturing a stomach using the apposition device according to theembodiments of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides an endoscopic stomach tissue appositiondevice capable of securing a plurality of tissue sites together with asingle intubation of an endoscope carrying the apposition device at thedistal end of the endoscope into the stomach of the patient. To positionthe suture in the appropriate locations, the apposition device may bereleasably secured to the distal end of any suitable endoscope. Theapposition device includes a tissue vacuum chamber that captures asection of stomach tissue therein, nesting carrier and punch needlesthat can extend across the vacuum chamber, and a tag that is joined to asuture to prevent the suture from falling out of the apposition device.

FIG. 4 shows the distal end of a flexible endoscope 100, on which anapposition device 110 according to the present invention is attached.The endoscope 100 is provided with a viewing channel (not shown) whichterminates at a lens (not shown) on the distal face of the endoscope100. The viewing channel and lens are conventional features well knownin the art of endoscopic devices.

The endoscope 100 is also provided with a working channel 115 and avacuum channel 120, wherein the proximal end 120 a of the vacuum channel120 is in communication with a vacuum source (not shown). Although thevacuum channel 120 may comprise a separate tube that runs exterior tothe endoscope 100, rather than an internal channel as shown, in oneembodiment it is preferable that the vacuum channel 120 include aninternal channel and have a distal end 120 b that terminates at aproximal vertical wall 130 a of a vacuum chamber 130, as shown in FIG.4, for reasons that will be provided below.

In exemplary arrangements, as shown in FIG. 4, a first or carrier needle140 having a beveled tip 141 extending toward the vacuum chamber 130 isdisposed in the working channel 115. The beveled tip 141 of the carrierneedle 140 is hollow and configured to receive a relatively shortersecond or punch needle 150 located on the distal end of the endoscope100 on the opposite or distal side of the vacuum chamber 130 relative tothe carrier needle 140. The punch needle 150 has a beveled tip 151 thatcorresponds to the beveled tip 141 of the traveling needle 140 and isconfigured to receive the beveled tip 141 of the carrier needle 140therein. The punch needle 150 is held within a holding channel 160located on the distal end of the endoscope 100 by a holding mechanism170.

FIG. 4A shows an enlarged view of the punch needle 150 of the embodimentof FIG. 4, which includes an aperture 152 and a notch 153. The aperture152 is configured to receive a suture or thread 180 thereinto, wherein adiameter of the aperture 152 is greater than a diameter of the suture180. A tag or other retaining feature 154 is affixed to the end of thesuture 180 and configured to be of a size greater than the diameter ofthe aperture 152, wherein the tag or other retaining feature 154 cannotpass through the aperture 152. The assembly of the suture 180 and tag154 is securely retained by the punch needle 150 throughout the surgicalprocedures in which the apposition device 110 is used. The notch 153 isconfigured to be releasably engaged, for example, by a pivotable key171, as shown in FIG. 4.

The present invention includes a hold and release mechanism. As shown inthe exemplary embodiment of FIG. 4, the holding channel 160 is coaxialto the working chamber 115. An aperture 116 located at a distal end 115a of the working chamber 115 is directly opposite an aperture 161 at aproximal end 160 a of the holding channel 160. Accordingly, whenactuated, the carrier needle 140 traverses and eventually spans thevacuum chamber 130, and enters the holding channel 160.

A release channel 190 is located directly above the holding channel 160in a normal (or perpendicular) direction relative to a bottom surface ofthe vacuum chamber 130. An aperture 191 at a distal end 190 a of therelease channel 190 is located in a corresponding location adjacent theaperture 161 for the holding channel 160. However, as shown in FIG. 4,the release channel 190 has a longitudinal length that is greater than alongitudinal length of the holding channel 160 for reasons providedbelow.

The holding mechanism 170 is located in the release channel 190 andincludes the pivotable key 171, which has a cam profile, a slottedmember 172, which has a vertically extending slot 172 a incorporatedtherein to receive a pivot end of the key 171, and a biasing member 173.The biasing member 173 includes a cylinder 174 slidably supported byfirst and second support struts 175 and 176. The support struts 175 and176 include apertures formed therein that are configured to slidablyreceive the cylinder 174 therein.

The cylinder 174 includes a stop 177 protruding therefrom at a locationon the cylinder 174 that is constantly intermediate the support struts175 and 176. A biasing member 178, such as, for example only, an elasticcoil, is wound around the cylinder 174 in a spiral manner such that afirst end of the coil 178 is constantly engaging the stop 177 protrudingfrom the cylinder 174 and a second end of the coil 178 engages thesecond support strut 176 located at the distal end of the endoscope 100.The notch 153 defined in the punch needle 150, the key 171, the aperture161, and the slotted member 172 define a reloading mechanism whichprepares the device 110 for the next stitch to be sewn.

FIGS. 4-10 will now be used to explain how the apposition or sewingdevice 110 operates to join neighboring sections of stomach tissuetogether using the exemplary device of FIGS. 4 and 4A.

Referring to FIGS. 4 and 4A, the apposition device 110 of the presentinvention is attached to the end of a flexible or rigid endoscope 100.The carrier needle 140 is maintained in a first position within theworking channel 115. During the first position, the punch needle 150 ismaintained within the holding channel 160 by the pivotable key 171 ofthe holding mechanism 170 engaging the notch 153 of the punch needle150. At the same time, the suture 180 passing through the aperture 152in the punch needle 150 is retained therein by the tag 154. Also, thefirst end of the cylinder 174 is free from or not engaging key 171.

Then, as shown in FIG. 5, the carrier needle 140 is actuated and thebeveled tip 141 of the needle 140 enters the vacuum chamber 130.Meanwhile, the punch needle 150 continues to be maintained in theholding channel 160 by the key 171. Further, the cylinder 174 continuesto be from engaging or contacting the key 171.

Upon totally crossing the vacuum chamber 130, the beveled tip 141 of thecarrier needle 140 enters and is engaged by the punch needle 150. SeeFIG. 6. Then, retraction of the nested carrier and punch needles 140 and150 begins, such that the needles 140 and 150 are drawn back toward theworking channel 115, and the key 171 is pivotably and slidablydisengaged from the notch 153 of the punch needle 150. When the needles140 and 150 initially are retracted, the key 171 begins traveling up theslotted member 172, wherein the cam of the key 171 contacts the end ofthe cylinder 174.

According to the exemplary embodiment of FIG. 4, the cam profile drivesthe cylinder 174 toward the distal most end of the endoscope 100 (towardthe right as viewed in FIG. 6). As the cylinder 174 is being drivendistally (i.e., to the right as viewed in FIG. 6), the stop 177extending away from an outer surface the cylinder 174 engages a firstend of the coil 178 while the second end of the coil 178 presses upagainst the support strut 176. The continued driving of the cylinder 174by the cam profile of the key 171 results in the compression of the coil178 between the moving stop 177 and the support strut 176. The distalmost end of the cylinder 174 extends into the distal end of the releasechannel 190 and beyond the distal end of the holding channel 160. SeeFIG. 7.

Once the nested needles 140 and 150 are retracted proximally to bedisposed within the working channel 115, the vacuum source (not shown)is turned on, such that a vacuum pressure is created in the vacuumchamber 130 via the vacuum channel 120. As a result, neighboringsections of stomach tissue are drawn into the vacuum chamber 130 anddistal end 120 b of the vacuum channel, via the vacuum pressure, to forma U-shaped portion of tissue 200 within the vacuum chamber 130. See FIG.8. Meanwhile, the biasing member or coil 178 continues to bias the stop177 away from the distal end of the endoscope 110, wherein the cylinder174 is driven toward the aperture 190 a of the release channel 190.

The nested needles 140 and 150 then pierce the U-shaped portion oftissue 200 when the nested needles 140 and 150 are actuated or drivenback across the vacuum chamber 130 toward the holding channel 160 in thedistal end of the endoscope 100. As shown in FIG. 9, the suture 180 isthreaded through the passage formed in the U-shaped portion of tissue200 by the tip 151 of the punch needle 150. As explained above, thesuture 180 is securely maintained in the punch needle 150 by the tag 154affixed to the end of the suture 180.

Once the punch needle 150 enters the holding channel 160, the carrierneedle 140 is released from the punch needle 150 and is retracted backinto the working channel 115. Then, because the carrier needle 140 is nolonger nested within the punch needle 140, the outer surface of thecarrier needle 140 does not prevent the key 171 from entering the notch153 of the punch needle 150. As such, the key 171 slides down theslotted member 172, such that a tip of the key 171 drops or extends intothe holding channel 160, whereupon the key 171 engages the notch 153 ofthe needle 150 and secures the needle 150 within the channel 160.

At this time, the vacuum source is turned off and the sutured U-shapedportion of tissue 200 retracts from the vacuum chamber 130, with thesuture 180 passing therethrough, as shown in FIG. 10.

As will be made clearer from the exemplary procedure illustrated inFIGS. 11-16, the apposition device 110 is then moved to another sectionof the stomach and the steps discussed above with regards to FIGS. 4-10repeated.

For example only, and in no way intended to limit the scope of thepresent invention or the various additional types of procedures duringwhich the invention can be used, the apposition device 110 of thepresent invention being used during a bariatric surgical process willnow be discussed in order to provide a better understanding of the manyways in which the invention may be operated.

Initially, the patient is anaesthetized and positioned to lay obliquerelative to a working surface, such as, for example, a surgical table.The apposition device 110 is positioned near the patient's gastricesophagus joint using a guide wire. The guide wire is then removed.

The bariatric surgical process is typically applied to the stomach of ahuman patient. In general, a human stomach has a preceding face, aposterior face, and a greater curvature extending therebetween. Duringsuch a procedure, the greater curvature of the stomach is closed withthe suture, which is ideally a non-absorbable cord that will extend fromthe near edge of the propyloric cavern to the gastric fundus. Asillustrated in FIG. 11, the suture is to be applied at alternatingpoints that are approximately 10 centimeters from one another.

Preferably, the bariatric surgical procedure is carried out with anendoscope 100 having an apposition device 110 attached to the distal endthereof. As shown in FIG. 11, the endoscope 100 and apposition device110 are inserted through the esophagus into the stomach of a patient.The device 110 is positioned over a plurality of alternating points,where U-shaped portions of stomach tissue 200 are sutured or sewntogether using the device and method described above in conjunction withFIGS. 4-10.

As shown in FIGS. 11-15, the stomach tissue at the alternating pointsare sequentially sutured together to define the revised stomach of FIG.16, which has a significantly reduced volume than before the procedure,as the anterior and posterior walls of the stomach are brought together.For example, it is estimated the process can be used to reduce the sizeof the gastric camera by approximately 50% top 60% with an approximatelyone hour procedure.

The first stitch is sewn approximately 2 centimeters (cm) from thegastric esophagus joint on the back face of the gastric fundus (FIG.11). The apposition device 110 is then moved forward approximately 10-12cm toward a gastric angle on the same back face, and the next stitch issewn as shown and described above in conjunction with FIGS. 4-10 (FIG.12). In order to maintain a sufficient length of the suture 180 withinthe stomach, the device 110 is moved away from the gastric wall andtowards the pylorus (FIG. 13). The apposition device 110 is then movedupwardly toward the gastric esophagus joint, in front of the secondstitch towards the rear wall of the stomach (FIG. 14). The next stitchis sewn as shown and described above in conjunction with FIG. 4-10.

The procedure is repeated wherein subsequent stitches are sewn in analternatingly left, then right, side manner and in an upward directionapproximately 1 to 1.5 cm apart until reaching a position on theopposite side of the stomach from the first stitch, about 2 cm from thegastric esophagus joint. The opposite ends of the suture 180 are thendrawn together (FIG. 15), wherein the fundus space and gastric body sizeare reduced (FIG. 16).

Once the procedure is completed, the apposition device 110 is withdrawnfrom the patient and the ends of the suture 180 tied together in a knotor retained together by a suitable retaining device, such as, abiodegradable stomach clamp or clip, that is then pushed back into thestomach of the patient, with excess suture then removed. See FIG. 15.

It is anticipated that the process be an ambulatory process that iscarried out using propofol intravenous anesthesiology, whereupon thepatient can expect to consume liquids as soon as six hours after theprocedure is completed.

While there has been described what is at present considered to be apreferred embodiment of the present invention, it will be understoodthat various modifications may be made thereto, and it is intended thatthe appended claims cover all such modifications as fall within the truespirit and scope of the invention.

For example, the aforementioned holding mechanism 170 is merely anexemplary embodiment of structural components that maybe used tointermittently retain the punch needle in the holding channel 160. It iswithin the scope of the invention to use any known or later developedsystem for performing such a function. For example, the punch needle 150may be retained in the holding channel 160 via friction, gravity,magnetic forces, electromagnetic forces, a solenoid member, and thelike. Moreover, the cam on the key 171, struts 175 and 176, as well asthe cylinder 174, stop 177, and coil 178 elements can be omitted so longas a suitable manner of facilitating the key 171 and notch 153 of thepunch needle 150 to intermittently engage and disengage from each otheris provided.

What is claimed is:
 1. An endoscopic tissue apposition device,comprising: a device body having a first end portion and a second endportion; a vacuum chamber within the device body for receiving tissuedrawn therein with a vacuum, the vacuum chamber being located betweenthe first end portion and the second end portion; a carrier needleretractable within the first end portion of the device body andtraversable across the vacuum chamber to the second end portion of thedevice body, the carrier needle including a beveled tip; a punch needleengageable with the second end portion of the device body, wherein thepunch needle is configured to receive the carrier needle; and a hold andrelease mechanism configured to intermittently retain the punch needlein the second end portion of the device body, the hold and releasemechanism including a holding channel and a release channel, the holdingchannel configured to releasably hold the punch needle therein, therelease channel including a holding mechanism therein, the holdingmechanism including a key having a pivot end, a slotted member having avertically extending slot configured to slidably receive the pivot endof the key therein, and a biasing member, wherein a suture is attachableto the punch needle, and wherein the punch needle with the attachedsuture is traversable across the vacuum chamber upon the carrier needlebeing received within the punch needle.
 2. The apposition deviceaccording to claim 1, wherein the punch needle includes a beveled tip.3. The apposition device according to claim 2, wherein the beveled tipof the punch needle corresponds to the beveled tip of the carrierneedle.
 4. The apposition device according to claim 2, wherein the punchneedle is hollow.
 5. The apposition device according to claim 1, furthercomprising a vacuum line communicating with the vacuum chamber forapplying a vacuum to the vacuum chamber.
 6. The apposition deviceaccording to claim 1, wherein the release channel has a longitudinallength greater than a longitudinal length of the holding channel.
 7. Theapposition device according to claim 1, wherein the punch needle furthercomprises: a notch configured to receive the key therein to prevent thepunch needle from sliding out of the holding channel; and a sutureaperture.
 8. The apposition device according to claim 7, wherein asuture passes through the suture aperture of the punch needle.
 9. Theapposition device according to claim 8, further comprising a tagattached to a free end of the suture, the tag being configured to belarger than the suture aperture to prevent the suture from falling outof the punch needle.
 10. The apposition device according to claim 9,wherein the biasing member comprises: a cylinder having a stopprotruding radially away from an outer surface of the cylinder; at leastone support strut having a through-hole formed therein through which thecylinder is longitudinally advanced; and a coil wound around the outersurface of the cylinder.
 11. The apposition device according to claim10, wherein a first end of the coil engages the stop and a second end ofthe coil engages the second support strut.
 12. The apposition deviceaccording to claim 11, wherein the key further includes a cam whichurges the cylinder toward a distal end of the device when the key slidesvertically upward as the punch needle is being removed from the holdingchannel and as the carrier needle is retracted back toward the workingchannel, and wherein the coil is compressed between the stop and secondsupport strut.